Vacancy caducado!
- Review, research, and interpret changes, trends and new developments related to human research.
- Provide written analysis on specified topics.
- Draft policies and procedures to implement and operationalize client and HRPP-related initiatives.
- Develop strategies to enable the client and HRPP and other implicated University Departments and personnel to successfully adapt to changes.
- Serve as a resource to the University community regarding human research matters.
- Demonstrated expertise and a comprehensive understanding of applicable legal, regulatory, and medical terminology and ability to interpret, analyze, apply, and communicate (verbally and in writing) applicable ethical principles, standards, regulations, guidance, policies, and academic and industry trends that impact human research.
- Demonstrated ability to manage, organize, and execute complex projects. Ability to multi-task, identify, analyze, and resolve problems efficiently and effectively, to use good, independent judgment and to assess risk. Ability to independently follow-through on tasks, develop and execute work plans, prioritize work, and manage multiple assignments to meet deadlines.
- Demonstrated ability to evaluate information, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and approaches. Ability to distill and communicate complex information into understandable information.
- Demonstrated ability to provide guidance regarding regulatory requirements and resolve issues. Ability to be proactive, flexible, and customer service-focused and to work effectively with others. Demonstration of ethics and integrity in professional matters, with sensitivity to confidentiality, and commitment to protecting research participants.
- Demonstrated technology and software application skills. Ability to learn new software packages. Highly skilled in office productivity software (e.g., Word, PowerPoint, Excel, e-mail, Outlook, and Adobe, etc.). Knowledge of technology platforms used in research (e.g., IRB management, clinical trial management, and related platforms).
- Advanced degree preferred (JD, PhD, MD, etc.).
- Research Compliance, Certified IRB Professional, or other relevant certification.
- Project, quality, or lean management certification.
- Experience in a leadership/consultancy role.
- Expert knowledge regarding Federally Funded/FDA regulated research regulations, ICH GCP, and the clinical trials process.
- Experience with international research standards.
Vacancy caducado!